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目的:制备吲哚美辛肠溶包衣微丸,考察其释放特性。方法:采用正交试验设计筛选微丸的处方、工艺参数,用滚动凝聚法制备素丸,用沸腾包衣技术制备微丸,通过溶出试验考察其释放特性。结果:以优选处方、工艺制备的微丸在规定的酸性介质中几乎不释放,而在磷酸盐缓冲液中则释放80%以上。结论:本品处方合理,制备工艺简单,能达到肠溶目的,可降低或消除吲哚美辛在临床上使用的毒副作用
Objective: To prepare indometacin enteric coated pellets and study their release characteristics. Methods: Orthogonal design was used to screen the prescription and process parameters of pellets. The pellets were prepared by rolling agglomeration method. The pellets were prepared by boiling coating technique. The release characteristics were investigated by dissolution test. Results: The pellets prepared by the preferred formulation and process were almost not released in the prescribed acidic medium, but released more than 80% in the phosphate buffer solution. Conclusion: This product is reasonable prescription, preparation process is simple, can achieve the purpose of enteric, can reduce or eliminate the side effects of indomethacin in clinical use